Effect of Food on the Pharmacokinetics of NNC0123-0000-0338 in a Tablet Formulation in Healthy Subjects

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: insulin 338 (GIPET I)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02304627

2014-000979-87 (EudraCT Number)

NN1953-3974

U1111-1154-0535 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to investigate the effect of food on the pharmacokinetics (the exposure of the trial drug in the body) of NNC0123-0000-0338 in a tablet formulation in healthy subjects.

Enrollment: 45 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18-64 years (both inclusive) at the time of signing informed consent
• Body mass index 18.5-28.0 kg/m^2 (both inclusive)
• Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion criteria

• Known or suspected hypersensitivity to trial products or related products
• Previous participation in this trial. Participation is defined as informed consent
• Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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45 participants in 4 patient groups

Eating meal immediately after dosing

Experimental group

Treatment:

Drug: insulin 338 (GIPET I)

Eating meal 30 min after dosing

Experimental group

Treatment:

Drug: insulin 338 (GIPET I)

Eating meal 1 hour after dosing

Experimental group

Treatment:

Drug: insulin 338 (GIPET I)

Eating meal 6 hour after dosing

Experimental group

Treatment:

Drug: insulin 338 (GIPET I)